Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain

Sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Study ID
NCT06716801
Status
Recruiting
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Conditions

  • Focal Epilepsy With and Without Secondary Generalization

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cenobamate — DRUG
    Adult patients affected by epilepsy with focal-onset seizures with or without secondary generalization who have not been adequately controlled despite a history of treatment with 2 or 3 anti-seizure medications.

Study Details

Aim of the study is to better characterize the clinical profile of adjunctive cenobamate by collecting data from the current standard clinical practice in France, Germany, and Spain, to describe the real-world clinical response among adult patients affected by focal epilepsy not adequately controlled despite a history of 2 or 3 ASMs before starting treatment with cenobamate (including previous and concomitant ASMs).

Key Dates

Start date
Dec 19, 2024
Status verified
Nov 2024
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Patients affected by epilepsy with focal-onset seizures with or without secondary generalization
    Adult patients affected by epilepsy with focal-onset seizures with or without secondary generalization who have not been adequately controlled despite a history of treatment with 2 or 3 anti-seizure medications (ASMs).

Primary Outcome Measure

Responder rate [ Time Frame: At 6 and at 12 months of maintenance treatment ]

Central Contacts